Oslo, Norway, 24 February 2003.
PhotoCure ASA announces today that the Australian Drug Evaluation Committee (ADEC) recommends the approval of the marketing authorisation application (MAA) for Metvix® PDT for the treatment of actinic keratosis (AK, pre-malignant skin lesion). According to the ADEC recommendation, the approval should be subject to finalisation of the Product Information to the satisfaction of the TGA (Therapeutic Goods Administration). The original MAA for the treatment of AK and basal cell carcinoma (BCC, skin cancer) was submitted to TGA in March 2001, and on request from TGA additional clinical data for the treatment of AK was submitted in June 2002.
Australia constitutes a very important market for PhotoCure, as this is the country with the highest frequency of sun-induced skin diseases in the world. Up to 50% of the Australian population over 40 years of age have AK and this gives a total of 2.5 million new AK-cases each year. Worldwide, it is estimated that approximately 20 million cases of AK occur every year.
Clinical testing of Metvix® PDT in Australia has been carried out by leading researchers in the field. As a result, PhotoCure has built strong relationships with these Australian researchers.